Quality Assurance on the Floor Specialist

United States, Walkersville (Maryland)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. 

The Quality Assurance on the Floor Specialist will be responsible for supporting Production in the execution of procedure and process in the GMP (Good Manufacturing Practice) environment. The role also includes Quality Assurance oversight of Facilities and Engineering work within the GMP areas and areas that impact GMP production.

Key responsibilities:

  • Observation of critical manufacturing process steps, clean room behavior and adherence to defined process parameters by performing walk-throughs of Production and support areas.
  • Review of batch records on the production floor ensuring completeness, accuracy of routine work as well as footnotes/ comments documented by production staff.
  • Support resolution of potential non conformance events by utilizing the deviation management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with production, QC, and other groups, as needed.
  • Advise production on proper documentation requirements as needed.

Key requirements:

  • Bachelor’s degree in life sciences preferred
  • Direct Quality Assurance product experience required or an equivalent amount of manufacturing/product management experience.
  • GMP compliance and Part 11 compliance knowledge preferred.
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations
  • The ability to interface and communicate directly with clients may be required.
  • Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
  • A strong sense of urgency to maintain project deadlines is required.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R25041